The results of the ILTE study published on the Journal of th National Cancer
Institute on March 23th 2011.Read the following press release

CML Patients Taking Imatinib Have Similar Mortality Rates to People in General Population

Patients taking imatinib (Gleevec) for CML, or chronic myelogenous leukemia, and in remission
after two years of treatment, have a mortality rate similar to that of the general population
according to a study published online March 22 in the Journal of the National Cancer Institute.
The article offers the first evidence that a disseminated cancer, not amenable to surgery, can be
controlled to the point of giving patients a normal life expectancy.

Many patients in this study, known as the Long-Term Imatinib Effects (ILTE) study, reported
side effects, but survival rates remained high even after eight years of taking the drug.

Imatinib was the first drug to produce complete and lasting responses in CML patients and is
now widely used as first-line treatment. But most information on the long-term effects of the
oral, targeted agent has come from industry-sponsored trials at selected centers. To learn about
outcomes in patients taking imatinib under normal circumstances, outside of trials, Carlo
Gambacorti-Passerini, M.D. of the University of Milano Bicocca/San Gerardo Hospital in
Monza, Italy and colleagues collected data on patients from 27 centers in Europe, North and
South America, Africa, the Middle East, and Asia.

The ILTE study enrolled 832 patients who were in complete remission after two years of taking
the drug. Twenty deaths occurred during the follow-up period, for a mortality rate of 4.8%--
similar to what would be expected in a comparable group of people in the general population.
Only six of these deaths were related to CML. Serious adverse events, such as cardiovascular
and digestive system problems, were reported in 139 patients, but were considered related to
imatinib in only 27 cases, or 19%.

Other adverse events, less serious but judged by treating physicians to substantially affect quality
of life, occurred in more than half of patients and were frequently linked to imatinib use. The
most frequent were muscle cramps, asthenia (weakness), edema, skin fragility, diarrhea, and
tendon or ligament lesions. Nineteen patients (or 2.3%) stopped taking imatinib because of side
effects; at least half of these switched to one of the other targeted drugs for CML, dasatinib or
nilotinib, which became available in 2006.

The authors conclude that patients on imatinib “frequently suffer from side effects that are non-
serious but can nonetheless reduce their quality of life.” They note that the findings highlight the
“importance of a good relationship between health care providers and patients, where side effects
are easily communicated and addressed to reduce/avoid non-compliance.”

In an accompanying editorial, B. Douglas Smith, M.D., of the Sidney Kimmel Comprehensive
Cancer Center at Johns Hopkins, Baltimore, writes that the study adds “real-life, long-term” data
on the efficacy and side effects of imatinib. “Remarkably, survival rates and the incidence of
secondary malignancies in this patient cohort did not differ statistically significantly from the
general population, which speaks to... the astounding effect [imatinib] has had on the clinical
course of this disease,” he writes.

ILTE is an independent, non company sponsored study and is funded by AIFA (Italian Drug Safety Agency) and Regione Lombardia, direzione sanità.